FAST-01: Feasibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases

Sponsor

Varian, a Siemens Healthineers Company (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04592887

Collaborator

(none)

Enrollment

Location

Arm

24.9

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This purpose of this study is to assess the feasibility of FLASH radiotherapy for the palliative treatment of painful bone metastases. FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment.

Condition or Disease	Intervention/Treatment	Phase
Bone Metastasis	Radiation: FLASH Radiotherapy	N/A

Detailed Description

This clinical investigation is designed to assess the workflow feasibility of FLASH radiotherapy treatment in a clinical setting, as well as the toxicities, and pain relief when used to treat bone metastasis(-es) in the extremities (excluding feet, hands, wrists). FLASH radiotherapy has been shown in preclinical studies to cause less injury to surrounding normal tissues during radiation treatment, while still having similar tumor cell killing. Patients at least 18 years of age with painful bone metastases located in the limbs will be considered for the study. These patients represent an ideal population for a feasibility study of FLASH radiotherapy as they are known to benefit from the palliative effects of radiotherapy using single dose radiation regimens of 8Gy which is what is being used in this investigation. After treatment, patients will be assessed for pain response as well as any adverse side-effects of radiation. The workflow feasibility of the treatment will also be evaluated.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Open label, single arm prospective feasibility studyOpen label, single arm prospective feasibility study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Feasibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases

Actual Study Start Date :

Nov 3, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FLASH radiotherapy for painful bone metastasis(-es)	Radiation: FLASH Radiotherapy FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment.

Arm

Intervention/Treatment

Experimental: FLASH radiotherapy for painful bone metastasis(-es)

Radiation: FLASH Radiotherapy

FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment.

Outcome Measures

Primary Outcome Measures

Workflow feasibility [Will be assessed on day of treatment delivery which occurs within 3 weeks of subject enrollment.]
Treatment for an individual subject will be deemed NOT feasible if total treatment time on table is greater than one hour .
Workflow feasibility [Will be assessed within 4 weeks of subject enrollment.]
Treatment for an individual subject will be deemed NOT feasible if delays in study treatment of more than 7 business days from simulation to treatment occurs related to the investigational device (excluding delays due to patient or facility factors not related to study treatment)
Assessment of radiation-related toxicities that are possibly, probably, or definitely related to FLASH radiotherapy. [Assessed from start of treatment until subject death or lost to follow-up]
Toxicities that are possibly, probably, or definitely related to FLASH radiotherapy. Toxicities will be classified per CTCAE version 5.0.

Secondary Outcome Measures

Pain relief [Assessed at Day 15, Months 1, 2, 3, long term; flare in bone pain assessed during the first 10 days after treatment]
Patient reported pain score overall and specifically for treated sites.
Use of pain medication. [Assessed at baseline and for the first 10 days after treatment.]
Use of pain medication.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient age at least 18 years
Up to 3 painful bone metastasis(-es) in the extremities
Bone metastases that can be treated using pre-defined treatment field sizes (7.5 cm x 7.5 cm; 7.5 cm x 10 cm; 7.5 cm x 12 cm; 7.5 cm x 14 cm; 7.5 cm x 16 cm; 7.5 cm x 18 cm; 7.5 cm x 20 cm), without overlap of radiation fields
Life expectancy of >2 months (in the judgement of the investigator)
Patients who are able to comply with the protocol
Provision of signed and dated informed consent form

Exclusion Criteria:

Prior radiotherapy to the treatment site(s)
Lesions of the feet, hands, wrists are not eligible treatment sites for FLASH
More than 3 painful bone metastases of the limbs requiring palliative radiotherapy
Tumor lysis of >50% of the circumferential bone cortex, or other factors considered to place the subject at significant risk of pathologic fracture
Patients with bone fractures and/or metal implants in the treatment field
Patients who will receive cytotoxic chemotherapy within 1 week prior to or 1 week following their planned radiation treatment
Prior local therapy modality to the treatment site(s) within 2 weeks of study enrollment
Patients with pacemakers or other implanted devices at risk of malfunction during radiotherapy
Patients with any other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical investigation
Patients at known risk of enhanced normal tissue sensitivity to radiotherapy due to inherited predisposition or documented comorbidity that might lead to hypersensitivity to ionizing radiation
Patients enrolled in any other clinical studies the investigator believes to be in conflict with this clinical investigation.
Patients who are pregnant or nursing